Elderly Patients Undergoing Elective Non-cardiac SurgeryNCT06530901
Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
An observational study of Elderly Patients Undergoing Elective Non-cardiac Surgery, run by Zhuan Zhang at 1 site in China.
Trial summary
Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Elderly Patients Undergoing Elective Non-cardiac Surgery
- What is being tested?
- Multidimensional ultrasound of the inferior vena cava
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients undergoing elective non-cardiac surgery under general anesthesia
Who may be able to join
- Elderly patients undergoing elective non-cardiac surgery under general anesthesia;
- Age 65-85 years old;
- Body mass index (BMI) 18-28 kg/m2;
- American society of anesthesiologists (ASA) class I-III.
Who cannot join
- Patient refusal or lack of cooperation;
- Inability to communicate properly;
- Severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation;
- Presence of severe hepatic and renal function abnormalities;
- Preoperative cardiac ultrasound suggesting LVEF <50%;
- Tricuspid valve displacement <16 mm by preoperative cardiac ultrasound;
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- Chronic obstructive pulmonary disease;
- Pulmonary hypertension;
- Administration of drugs that inhibit the renin-angiotensin-aldosterone system;
- Possibility of a difficult airway.
Trial locations and contacts
1 site in 1 country.
China1 site
the Affiliated Hospital of Yangzhou University, Yangzhou University
Yangzhou, Jiangsu
About this study
Official title: Multidimensional Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.
- Being tested
- Multidimensional ultrasound of the inferior vena cava
- Keywords
- hypotension, general anesthesia, inferior vena cava
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional ultrasound of the inferior vena cavaDiagnostic test
Cross-sectional parameters of the inferior vena cava include two-dimensional longitudinal diameter, cross-sectional length and short diameter, circumference, and cross-sectional area, as well as cross-sectional length and short diameter, circumference, and cross-sectional area in three-dimensional imaging
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients undergoing elective noncardiac surgery under general anesthesia | Not described Receives: Diagnostic Test: Multidimensional ultrasound of the inferior vena cava |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the level of Mean Arterial Pressure
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Measured: Baseline (before induction), 10 min after induction
Changes in the level of Systolic Blood Pressure
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Measured: Baseline (before induction), 10 min after induction
Multidimensional ultrasound of the inferior vena cava
The outcome above should be measured at the time before induction
Measured: Baseline (before induction)
Secondary outcomes (2)
Changes in the level of Heart Rate
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Measured: Baseline (before induction), 10 min after induction
Changes in the level of Diastolic Blood Pressure
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Measured: Baseline (before induction), 10 min after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Patients Undergoing Elective Non-cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhuan Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuan Zhang, Yangzhou University
- Investigators
- zhuan zhang, professor, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530901
- Sponsor's protocol ID
- 20240725
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidimensional Ultrasound of the Inferior Vena Cava in the Prevention of Hypotension After Induction of General Anesthesia
- ClinicalTrials.gov ID
- NCT06530901
- Acronym / sponsor ID
- 20240725
- Keywords
- hypotension, general anesthesia, inferior vena cava
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhuan ZhangUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on the preoperative ultrasound detection of various parametric indicators of the inferior vena cava cross-section, including the ratio of the inferior vena cava's long and short axes, cross-sectional area and circumference during two-dimensional and three-dimensional imaging, as well as the changes in respiratory variability of each parameter, we explored the predictive value of IVC ultrasound indicator parameters on hypotension after induction of general anesthesia in elderly patients undergoing elective non-cardiac surgery, screened the sensitive indicators, and calculated the cut-off values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients undergoing elective noncardiac surgery under general anesthesia | – | Diagnostic Test: Multidimensional ultrasound of the inferior vena cava |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients undergoing elective non-cardiac surgery under general anesthesia
Key inclusion criteria (4 listed)
- Elderly patients undergoing elective non-cardiac surgery under general anesthesia;
- Age 65-85 years old;
- Body mass index (BMI) 18-28 kg/m2;
- American society of anesthesiologists (ASA) class I-III.
Key exclusion criteria (10 listed)
- Patient refusal or lack of cooperation;
- Inability to communicate properly;
- Severe sinus bradycardia, pacemaker implantation, atrioventricular block, and atrial fibrillation;
- Presence of severe hepatic and renal function abnormalities;
- Preoperative cardiac ultrasound suggesting LVEF <50%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional ultrasound of the inferior vena cavaCross-sectional parameters of the inferior vena cava include two-dimensional longitudinal diameter, cross-sectional length and short diameter, circumference, and cross-sectional area, as well as cross-sectional length and short diameter, circumference, and cross-sectional area in three-dimensional imaging | Diagnostic test | Elderly patients undergoing elective noncardiac surgery under general anesthesia |
Primary outcome
Changes in the level of Mean Arterial Pressure
Time frame: Baseline (before induction), 10 min after induction
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Changes in the level of Systolic Blood Pressure
Time frame: Baseline (before induction), 10 min after induction
The outcome above should be measured at the time before induction, 1 min after induction, 2 min after induction, 3 min after induction, 4 min after induction, 5 min after induction,10 min after induction
Multidimensional ultrasound of the inferior vena cava
Time frame: Baseline (before induction)
The outcome above should be measured at the time before induction
2 secondary outcomes
Changes in the level of Heart Rate
Time frame: Baseline (before induction), 10 min after induction
Changes in the level of Diastolic Blood Pressure
Time frame: Baseline (before induction), 10 min after induction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhuan zhang, professor principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly Patients Undergoing Elective Non-cardiac Surgery, run by Zhuan Zhang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhuan zhang, professor (+8615062791355, zhangzhuancg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the level of Mean Arterial Pressure (time frame: Baseline (before induction), 10 min after induction). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.